Tissue repair and fixation system and methods

ABSTRACT

A tissue repair or fixation system comprises an implant and a delivery tool configured to deploy the implant at least partially into tissue of a patient. The implant includes first and second tissue anchors and an adjustable suture assembly coupled thereto. The adjustable suture assembly includes a knotless locking element.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.14/182,112 filed Feb. 17, 2014, now U.S. Pat. No. 9,795,372, which is acontinuation of application Ser. No. 12/853,897 filed Aug. 10, 2010, nowU.S. Pat. No. 8,652,153, which claims the benefit of U.S. ProvisionalApplication Nos. 61/293,939, Filed Jan. 11, 2010, and 61/323,679 filedApr. 13, 2010, the disclosures of which are incorporated herein byreference in their entireties.

TECHNICAL FIELD

The invention generally relates to methods and devices for the closure,sealing, repair and/or reconstruction of an intervertebral disc annulus,and accompanying delivery devices and tools, and their methods of use.

BACKGROUND

The spinal column is formed from a number of bony vertebrae, which intheir normal state are separated from each other by intervertebraldiscs. These discs are comprised of the annulus fibrosus, and thenucleus pulposus, both of which are soft tissue. The intervertebral discacts in the spine as a crucial stabilizer, and as a mechanism for forcedistribution between adjacent vertebral bodies. Without a competentdisc, collapse of the intervertebral disc may occur, contributing toabnormal joint mechanics and premature development of degenerativeand/or arthritic changes.

The normal intervertebral disc has an outer ligamentous ring called theannulus surrounding the nucleus pulposus. The annulus binds the adjacentvertebrae together and is constituted of collagen fibers that areattached to the vertebrae and cross each other so that half of theindividual fibers will tighten as the vertebrae are rotated in eitherdirection, thus resisting twisting or torsional motion. The nucleuspulposus is constituted of soft tissue, having about 85% water content,which moves about during bending from front to back and from side toside.

The aging process contributes to gradual changes in the intervertebraldiscs. Fissures in the annulus fibrosus can occur due to various causes,including disease or other pathological conditions, or the natural agingprocess. Occasionally fissures may form rents through the annular wall.In these instances, the nucleus pulposus is urged outwardly from thesubannular space through a rent, often into the spinal column. Extrudednucleus pulposus can, and often does, mechanically press on the spinalcord or spinal nerve rootlet. This painful condition is clinicallyreferred to as a ruptured or herniated disc.

In the event of annulus rupture, the subannular nucleus pulposusmigrates along the path of least resistance forcing the fissure to openfurther, allowing migration of the nucleus pulposus through the wall ofthe disc, with resultant nerve compression and leakage of chemicals ofinflammation into the space around the adjacent nerve roots supplyingthe extremities, bladder, bowel and genitalia. The usual effect of nervecompression and inflammation is intolerable back or neck pain, radiatinginto the extremities, with accompanying numbness, weakness, and in latestages, paralysis and muscle atrophy, and/or bladder and bowelincontinence. Additionally, injury, disease or other degenerativedisorders may cause one or more of the intervertebral discs to shrink,collapse, deteriorate or become displaced, herniated, or otherwisedamaged and compromised.

SUMMARY

The various embodiments of the present invention relate to system forintervertebral disc annulus repair. Accordingly, Example 1 of thepresent invention is a device for at least partially closing an aperturein an annulus fibrosus of an intervertebral disc of a patient, thedevice comprising an implant delivery tool and an implant releasablycoupled to the implant delivery tool. The implant delivery tool includesa substantially rigid outer tube having a proximal section and asharpened distal tip, a body coupled to the proximal section of theouter tube, and a plunger assembly movable axially relative to the bodyand including a plunger member and a pusher tube coupled thereto anddisposed within the outer tube. The implant includes first and secondtissue anchors serially disposed within the distal section of the outertube, and a flexible connecting element coupling the first and secondtissue anchors, the connecting element at least partially formed from abraided tubular suture material. The braided suture material includes adistal segment attached to the first tissue anchor, an intermediatesegment extending proximally from the distal segment and including alocking element and an adjustable loop, wherein a portion of theintermediate segment extends internally within the braided suturematerial of the locking element, and wherein the second tissue anchor isslidably coupled to the braided suture material of the adjustable loop,and a proximal segment of the braided suture material extendingproximally from the intermediate segment and releasably coupled to theimplant delivery tool.

In Example 2, the device of Example 1 wherein the pusher tube isdisplaceable within the outer tube from a first position to a secondposition to eject the first tissue anchor from the outer tube.

In Example 3, the device of Example 1 or 2 wherein the pusher tube isfurther displaceable within the outer tube from the second position to athird position to eject the second tissue anchor from the outer tube.

In Example 4, the device of any of Examples 1 through 3 wherein theimplant delivery tool includes a releasable tab releasably coupled tothe plunger assembly.

In Example 5, the device of Example 4 wherein the connecting element ispartially disposed within the outer tube and the proximal segment of theflexible connecting element is coupled to the releasable tab of theimplant delivery tool.

The present invention, according to Example 6, is an implant for atleast partially closing an aperture in an annulus fibrosus of anintervertebral disc of a patient. The implant comprises first and secondtissue anchors sized and shaped to be disposed in a tubular member of adelivery tool and to be inserted into or through a portion of theannulus fibrosus, and a flexible connecting element coupling the firstand second tissue anchors. The connecting element is at least partiallyformed from a tubular braided suture material and includes a distalsegment of the braided suture material attached to the first tissueanchor, an intermediate segment of the braided suture material extendingproximally from the distal segment and including a locking element andan adjustable loop, wherein a portion of the intermediate segmentextends internally within the braided suture material of the lockingelement, and wherein the second tissue anchor is slidably coupled to thebraided suture material of the adjustable loop, and a proximal segmentof the braided material extending proximally from the intermediatesegment and operable by a user to be placed in tension to reduce thelength of the adjustable loop.

The present invention, in Example 7, is a device for at least partiallyclosing an aperture in an annulus fibrosus of an intervertebral disc ofa patient, the device comprising an implant delivery tool and an implantreleasably coupled to the implant delivery tool. The implant deliverytool includes a substantially rigid outer tube having a proximalsection, an intermediate section, and a distal section terminating in asharpened tissue-piercing distal tip having an open end. Theintermediate section has a first length, wherein the proximal and distalsections are laterally offset from one another by the intermediatesection. The implant delivery tool further includes a body coupled tothe proximal section of the outer tube, a plunger assembly including aplunger member slidably disposed within the body, and a pusher tubeslidably disposed within the body and the outer tube and coupled to theplunger member. The pusher tube includes a distal end and a flexiblesegment proximal to the distal end axially coincident with theintermediate portion of the outer tube. The flexible segment has asecond length greater than the first length of the intermediate portionof the outer tube. The implant includes a pair of tissue anchorsserially disposed within the distal section of the outer tube, and anadjustable flexible connecting element connecting the tissue anchors.The plunger assembly is operable by a user to selectively displace thepusher tube distally within the outer tube so as to serially eject thefirst tissue anchor and then the second tissue anchor from the open endof the outer tube.

In Example 8, the device of Example 7 wherein the pusher tube isdisplaceable within the outer tube from a first position to a secondposition to eject the first tissue anchor from the outer tube.

In Example 9, the device of Example 8 wherein the pusher tube is furtherdisplaceable within the outer tube from the second position to a thirdposition to eject the second tissue anchor from the outer tube.

In Example 10, the device of Examples 8 or 9 wherein the intermediatesection of the outer tube is axially coincident with at least a portionof the flexible segment of the pusher tube when the pusher tube is inthe first, the second and the third positions.

In Example 11, the device of any of Examples 7 through 10 wherein theimplant delivery tool includes a releasable tab coupled to the plungerassembly.

In Example 12, the device of Example 11 wherein a first portion of theconnecting element is disposed within the outer tube and a secondportion of the flexible connecting element is coupled to the releasabletab of the implant delivery tool.

In Example 13, the device of any of Examples 7 through 12 wherein theflexible connecting element has an adjustable length so as to allowseparation between the tissue anchors to be reduced after deployment.

In Example 14, the device of any of Examples 7 through 13 wherein theflexible connecting element is a knotless suture arrangement including alocking element substantially preventing elongation of the flexibleconnecting element between the tissue anchors after deployment.

In Example 15, the device of any of Examples 7 through 14 wherein theflexible segment of the pusher tube includes a series of slots extendingcircumferentially about the pusher tube in a helical pattern, the slotsimparting lateral flexibility to the flexible segment.

In Example 16, the device of Example 15 wherein the slots have anundulating shape.

In Example 17, the device of any of Examples 7 through 14 wherein theflexible segment of the pusher tube is heat treated to impart lateralflexibility to the flexible segment.

In Example 18, the device of any of Examples 7 through 14 wherein theflexible segment of the pusher tube is in the form of a helical spring.

In Example 19, the device of any of Examples 7 through 18 wherein theproximal and distal sections of the outer tube are substantiallyparallel to one another.

In Example 20, the device of any of Examples 7 through 19 wherein theintermediate section of the outer tube has a first curved portionextending from the proximal section and a second curved portionextending proximally from the distal section having an oppositecurvature to that of the first curved portion.

The present invention, according to Example 21, is a device for at leastpartially closing an aperture in an annulus fibrosus of anintervertebral disc of a patient, the device comprising an implantdelivery tool and an implant releasably coupled to the implant deliverytool. The implant delivery tool includes a substantially rigid outertube having a proximal section, a distal section, and an intermediatesection having a non-linear shape laterally offsetting the proximal anddistal sections from one another. The implant delivery tool furtherincludes a body coupled to the proximal section of the outer tube, aplunger assembly movable axially relative to the body and including aplunger member and a pusher tube coupled thereto and disposed within theouter tube. The pusher tube has a substantially rigid proximal segment,a substantially rigid distal segment including a distal end, and aflexible segment between the proximal and distal segments. The pushertube is slidably displaceable within the outer tube to assume aplurality of positions, and the flexible segment is configured toconform to the nonlinear shape of the intermediate section of the outertube in each of the plurality of positions of the pusher tube. Theimplant includes a pair of tissue anchors serially disposed within thedistal section of the outer tube, and an adjustable flexible connectingelement connecting the tissue anchors.

In Example 22, the device of Example 21 wherein the flexible segment ofthe pusher tube is dimensioned such that the intermediate section of theouter tube is axially coincident with at least a portion of the flexiblesegment in each of the plurality of positions of the pusher tube.

In Example 23, the device of Example 21 or 22 wherein the proximal anddistal sections of the outer tube are substantially parallel to oneanother.

In Example 24, the device of any of Examples 21 through 23 wherein theadjustable flexible connecting element is a knotless suture arrangementincluding a locking element substantially preventing elongation of theflexible connecting element between the tissue anchors after deployment.

In Example 25, the device of any of Examples 21 through 24 wherein theflexible segment of the pusher tube includes a series of slots extendingcircumferentially about the pusher tube in a helical pattern, the slotsimparting lateral flexibility to the flexible segment.

The present invention, according to Example 26, is a system for at leastpartially closing an aperture in an annulus fibrosus of anintervertebral disc of a patient, the system comprising first and secondrepair devices each including an implant delivery tool and an implantreleasably coupled to the implant delivery tool including. The implantdelivery tool includes a substantially rigid outer tube having aproximal section and a distal section terminating in a sharpened distaltip, a body coupled to the proximal section of the outer tube, and aplunger assembly movable axially relative to the body and including apusher tube disposed within the outer tube, wherein the pusher tube isslidably displaceable within the outer tube to assume a plurality ofpositions. The implant includes first and second tissue anchors seriallydisposed within the distal section of the outer tube, and a flexibleconnecting element coupling the first and second tissue anchors. Theflexible connecting element is at least partially formed from a braidedtubular suture material and includes a distal segment of the braidedsuture material attached to the first tissue anchor, an intermediatesegment of the braided suture material extending proximally from thedistal segment and including a locking element and an adjustable loop,wherein a portion of the intermediate segment extends internally withinthe braided suture material of the locking element, and wherein thesecond tissue anchor is slidably coupled to the braided suture materialof the adjustable loop, and a proximal segment of the braided suturematerial extending proximally from the intermediate segment andreleasably coupled to the implant delivery tool.

The present invention, according to Example 27, is an instrument for usein implanting a suture assembly. The instrument comprises a body havinglongitudinal axis, a first end, and a second end. The first end has acanted tip and a first slot therein sized to slidingly receive a portionof the suture assembly. The second end has a tip with a second slottherein sized to receive a portion of the suture assembly. Theinstrument further comprises a recessed blade with a cutting edgeexposed within the second slot. The cutting edge is configured to cutthe suture assembly.

In Example 28, the instrument of Example 27 wherein the cutting edge ofthe blade is oriented toward the tip of the second end of the body.

In Example 29, the instrument of either of Examples 27 or 28 wherein atleast a portion of the blade is oriented at an angle to the longitudinalaxis.

In Example 30, the instrument of any of Examples 27 through 29 whereinthe blade includes a coating.

In Example 31, the instrument of Example 30 wherein the coating includestitanium nitride.

The present invention, according to Example 32, is an implant for use inan orthopedic repair procedure to repair a tissue defect. The implantcomprises first and second tissue anchors and a flexible connectingelement. The first and second tissue anchors are sized and shaped to bedisposed in a tubular member of a delivery tool and to be inserted intoor through tissue proximate the defect. The flexible connecting elementcouples the first and second tissue anchors and is at least partiallyformed from a tubular braided suture material. The connecting elementincludes a distal segment of the braided suture material attached to thefirst tissue anchor, an intermediate segment of the braided suturematerial extending proximally from the distal segment and including alocking element and an adjustable loop, wherein a portion of theintermediate segment extends internally within the braided suturematerial of the locking element, and wherein the second tissue anchor isslidably coupled to the braided suture material of the adjustable loop.The connecting element further includes a a proximal segment of thebraided material extending proximally from the intermediate segment andoperable by a user to be placed in tension to reduce the length of theadjustable loop.

The present invention, according to Example 34, is an intervertebraldisc repair system comprising an implant and a delivery tool. Theimplant includes an anchor member and an adjustable suture assemblycoupled thereto. The adjustable suture assembly forms an adjustable loopand includes a tension line having a proximal end, and a toggle linecoupled to the anchor member for selectively rotating the anchor memberduring deployment thereof. The delivery tool includes a proximal handle,an outer tubular member, a needle cannula, an inner pusher member, andan actuating mechanism. The outer tubular member extends distally fromthe handle and has an open distal end. The needle cannula is slidablyreceived within the outer tubular member and has a proximal portion witha proximal end, and an open distal end terminating with a sharpened tipfor penetrating tissue. The inner pusher member is slidably receivedwithin the needle cannula and has a proximal end and a distal end. Theactuating mechanism is coupled to the handle for selectively retractingthe needle cannula relative to the outer tubular member and the innerpusher member. The proximal end of the tension line of the implant isoperable by the user to reduce at least one dimension of the loop. Theanchor member and at least a portion of the adjustable suture assemblyof the implant are releasably received within the needle cannula distalto the distal end of the inner pusher member. The delivery tool isconfigured such that actuation of the actuating mechanism proximallyretracts the needle cannula relative to the outer tubular member and theinner pusher member to release the anchor member from the needlecannula, and the toggle line of the adjustable suture assembly of theimplant is operable to cause rotation of the anchor member as the anchormember is released from the needle cannula.

In Example 35, the system of Example 34 wherein the delivery tool isconfigured such that the needle cannula and the inner pusher member canbe axially advanced together relative to the outer tubular member.

In Example 36, the system of Examples 34 or 35 wherein the delivery toolis configured such that the needle cannula is retractable relative tothe inner pusher member upon actuation of the actuating member afteraxially advancing the needle cannula and the inner pusher memberrelative to the outer tubular member.

In Example 37, the system of any of Examples 34 through 36 wherein thedelivery tool is configured to prevent proximal movement of the innerpusher member upon retraction of the needle cannula relative to theinner pusher member and the outer tubular member.

In Example 38, the system of any of Examples 34 through 37 wherein theadjustable suture assembly includes a knotless locking elementconfigured to prevent elongation of the adjustable loop.

In Example 39, the system of any of Examples 34 through 38 wherein thehandle of the delivery tool includes a tubular upper portion having aproximal end, and a lower portion extending from the upper portionadapted to be gripped by the user, wherein the outer tubular memberextends distally from the tubular upper portion of the handle such thatthe upper portion of the handle and the outer tubular member define alongitudinal axis of the delivery tool, and wherein the needle cannulaand the inner pusher member of the delivery tool are aligned with thelongitudinal axis.

In Example 40, the system of any of Examples 34 through 39 wherein theproximal end of the inner pusher member further includes an end plateextending radially from the inner pusher member.

In Example 41, the system of any of Examples 34 through 40 wherein thedelivery tool includes a releasable tab coupled to the proximal end ofthe second implant tension line, the releasable tab operable by the userto apply tension to the tension line to reduce the at least onedimension of the loop, the releasable tab further releasably coupled tothe inner pusher member between the end plate and the proximal end ofthe upper portion of the handle preventing axial movement of the innerpusher member.

In Example 42, the system of any of Examples 34 through 41 wherein theproximal portion of the needle cannula further includes a flange havingan aperture therein, and wherein the toggle line has a proximal endportion connected to the flange.

In Example 43, the system of any of Examples 34 through 42 wherein thedelivery tool is further configured such that actuation of the actuatingmechanism proximally retracts the needle cannula thereby applyingtension to the toggle line to rotate the anchor member as the anchormember is released from the needle cannula.

In Example 44, an intervertebral disc repair system for repairing adefect in an intervertebral disc of a patient, the system comprising afirst implant and a first delivery tool, and a second implant and asecond delivery tool. The first implant includes first and second tissueanchors, and an adjustable connecting element connecting the first andsecond tissue anchors, the adjustable connecting element having anadjustable length between the first and second tissue anchors. The firstdelivery tool includes a tissue penetrating tubular member, the firstand second tissue anchors releasably received in the tubular member, thefirst delivery tool configured to deploy the first and second tissueanchors in the intervertebral disc. The second implant includes ananchor member and an adjustable suture assembly coupled thereto, theadjustable suture assembly forming an adjustable loop and including atension line having a proximal end operable by a user to reduce at leastone dimension of the adjustable loop, and a toggle line coupled to theanchor member for rotating the anchor member during deployment thereof.The second delivery tool includes a proximal handle, an outer tubularmember, a needle cannula, an inner pusher member, and an actuatingmechanism. The outer tubular member extends distally from the handle andhas an open distal end. The needle cannula is slidably received withinthe outer tubular member and has a proximal portion with a proximal endand an open distal end terminating with a sharpened tip for penetratingtissue. The inner pusher member is slidably received within the needlecannula and has a proximal end and a distal end. The actuating mechanismis coupled to the handle for selectively adjusting an axial position ofthe needle cannula relative to the outer tubular member and the innerpusher member. The anchor member and at least a portion of theadjustable suture assembly of the second implant are releasably receivedwithin the needle cannula of the second delivery tool. The toggle lineof the adjustable suture assembly of the second implant is operable tocause rotation of the anchor member during deployment thereof uponactuation of the actuating mechanism by a user. The adjustable sutureassembly and the connecting element are configured to be interconnectedand placed under tension after deployment of the anchor member and thefirst and second tissue anchors.

In Example 45, the system of Example 44 wherein the second delivery toolis configured such that the needle cannula and the inner pusher membercan be axially advanced together relative to the outer tubular member.

In Example 46, the system of Examples 44 or 45 wherein the seconddelivery tool is further configured such that the needle cannula isretractable relative to the inner pusher member upon actuation of theactuating member after axially advancing the needle cannula and theinner pusher member relative to the outer tubular member.

In Example 47, the system of any of Examples 44 through 46 wherein thesecond delivery tool is configured to prevent proximal movement of theinner pusher member during retraction of the needle cannula relative tothe inner pusher member and the outer tubular member so as to cause theanchor member to be released from the needle cannula.

In Example 48, the system of any of Examples 44 through 47 wherein thesecond delivery tool includes a releasable tab coupled to the proximalend of the second implant tension line, the releasable tab operable bythe user to apply tension to the tension line to reduce the at least onedimension of the loop.

In Example 49, the system of any of Examples 44 through 48 wherein thesecond delivery tool is configured such that actuation of the actuatingmechanism proximally retracts the needle cannula relative to the outertubular member and the inner pusher member to release the anchor memberfrom the needle cannula.

In Example 50, the system of any of Examples 44 through 49 wherein theproximal portion of the needle cannula of the second delivery toolfurther includes a flange having an aperture therein, and wherein thetoggle line has a proximal end portion connected to the flange.

In Example 51, the system of any of Examples 44 through 50 wherein thesecond delivery tool is further configured such that actuation of theactuating mechanism proximally retracts the needle cannula therebyapplying tension to the toggle line as the anchor member is releasedfrom the needle cannula.

In Example 51, the system of any of Examples 447 through 51 wherein thehandle of the second delivery tool includes a tubular upper portionhaving a proximal end and a lower portion extending from the upperportion adapted to be gripped by the user, wherein the outer tubularmember extends distally from the tubular upper portion of the handlesuch that the upper portion of the handle and the outer tubular memberdefine a longitudinal axis of the second delivery tool, and wherein theneedle cannula and the inner pusher member of the second delivery toolare aligned with the longitudinal axis.

In Example 53, the system of any of Examples 44 through 52 wherein theproximal end of the inner pusher member extends proximally from theupper portion of the second delivery tool handle.

In Example 54, the system of any of Examples 44 through 53 wherein theproximal end of the inner pusher member further includes an end plateextending radially from the inner pusher member relative to thelongitudinal axis.

In Example 55, the system of any of Examples 44 through 54 wherein thereleasable tab is releasably coupled to the inner pusher member betweenthe end plate and the proximal end of the upper portion of the handlepreventing axial movement of the inner pusher member.

In Example 56, the system of any of Examples 44 through 55 furthercomprising a tension guide including a first end having a canted tip anda first slot therein sized to slidingly receive portions of theconnecting element of the first implant and the suture assembly of thesecond implant, and a second end having a tip with a second slottherein, and a recessed blade with a cutting edge exposed within thesecond slot. The second slot is sized to slidingly receive portions ofthe connecting element of the first implant and the suture assembly ofthe second implant. The cutting edge is configured to cut the connectingelement and the suture assembly to remove excess portions thereof.

In Example 57, the system of Example 56 wherein the cutting edge of thetension guide blade is oriented toward the tip of the second end of thetension guide.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a device for use in repairing an aperture or a defectin an annulus fibrosus of an intervertebral disc according to anembodiment of the present invention.

FIGS. 2A, 2B and 2C are partial cutaway views of an implant deliverytool of the device of FIG. 1 according to one embodiment of the presentinvention.

FIG. 3 is an elevation view of a plunger assembly of the implantdelivery tool shown in FIG. 2, including a pusher tube according to oneembodiment of the present invention.

FIG. 4 is a schematic view illustrating a slot arrangement for impartingflexibility in a flexible segment of the pusher tube of FIG. 3 accordingto one embodiment of the present invention.

FIGS. 5A-5C are schematic views of an implant for use in the repairdevice of FIG. 1 according to one embodiment of the present invention.

FIGS. 6A-6C are schematic views of an alternative implant for use in therepair device of FIG. 1 according to one embodiment of the presentinvention.

FIG. 7 is a schematic illustration of an alternative device for use inrepairing an aperture or a defect in an annulus fibrosus of anintervertebral disc using the implants of FIGS. 5A-5C and 6A-6Caccording to another embodiment of the present invention.

FIGS. 8A-8C are schematic illustrations showing the annulus fibrosusrepair device of FIG. 1 in use during a repair procedure on an annulusfibrosus.

FIGS. 9A-9C are plan and partial cut-away elevation views of an implantdelivery tool with an implant coupled thereto according to oneembodiment of the present invention.

FIGS. 10A-10C are plan and cross-sectional elevation views of a handleand outer tubular member of the delivery tool of FIGS. 9A-9C accordingto one embodiment of the present invention.

FIGS. 11A-11C are top, elevation and end views of a needle cannula ofthe delivery tool of FIGS. 9A-9C according to one embodiment of thepresent invention.

FIG. 12 is an elevation view of a pusher tube of the delivery tool ofFIGS. 9A-9C according to one embodiment of the present invention.

FIG. 13 is a schematic illustration of the implant of FIGS. 9A-9Caccording to one embodiment of the present invention.

FIGS. 14A-14E are partial cut-away elevation views of the implantdelivery tool of FIGS. 9A-9C during use to deploy the implant partiallywithin a vertebra of a patient.

FIG. 15A-15F are schematic illustrations showing the implant of FIGS.9A-9C being deployed in conjunction with a second implant tore-approximate an aperture or defect in a patient's intervertebral discaccording to one embodiment of the present invention.

FIGS. 16A-16B are elevation views of an alternative implant deliverytool with an implant coupled thereto according to another embodiment ofthe present invention.

FIGS. 17A-17D are elevation, detail perspective and partialcross-sectional views of a tension guide for use in conjunction with theimplants of FIGS. 5A-5B, 6A-6B, and 13 according to one embodiment ofthe present invention.

FIGS. 18A-18B are schematic illustrations showing the implant of FIG.5A-5B or 6A-6B implanted to repair a defect or tear in a meniscus of theknee according to one embodiment of the present invention.

While the invention is amenable to various modifications and alternativeforms, specific embodiments have been shown by way of example in thedrawings and are described in detail below. The intention, however, isnot to limit the invention to the particular embodiments described. Onthe contrary, the invention is intended to cover all modifications,equivalents, and alternatives falling within the scope of the inventionas defined by the appended claims.

DETAILED DESCRIPTION

FIG. 1 illustrates a repair device 10 for use in repairing an apertureor a defect in an annulus fibrosus of an intervertebral disc accordingto an embodiment of the present invention. As shown in FIG. 1, therepair device 10 includes an implant delivery tool 20 and an implant 25coupled thereto for deployment in intervertebral disc tissue. As furthershown, the implant delivery tool 20 includes an outer tube 30, a body35, a plunger assembly 40, and a releasable tab 42. In the illustratedembodiment, the body 35 is fixedly attached to the outer tube 30, andthe plunger assembly 40 is partially disposed within the body 35. Thetab 42 is releasably coupled to the plunger assembly 40. The implantdelivery tool 20 is configured such that the outer tube 30 can bepartially inserted into soft tissues of the intervertebral disc (e.g.,the annulus fibrosus) for delivery of the implant 25, with the plungerassembly 40 being configured to facilitate deployment of the implant.

As shown and described in further detail below, the implant 25 ispartially disposed within a portion of the implant delivery tool 20prior to deployment. Additionally, the implant 25 includes a tensionline 50 extending external to the outer tube 30 and connected to the tab42. The implant 25 is configured to facilitate full or partial closureof an aperture (e.g., a defect resulting from a herniated and rupturedannulus, or an opening from an incision made by a physician in adiscectomy procedure) by drawing together the annulus fibrosus tissuesdefining the aperture under tension (i.e., re-approximating the annulusfibrosus). The tab 42 is positioned, in the undeployed state of FIG. 1,so as to prevent spontaneous axial movement of the plunger assembly 40and, in turn, unintended deployment of the implant 25. Additionally, thetension line 50 is connected to the tab 42, which can be manipulated bythe user to apply tension to the tension line 50 to facilitate finaldeployment of the implant 25 (as discussed in further detail below).

FIGS. 2A, 2B and 2C are partial cutaway views of an implant deliverytool 20 of the repair device 10 of FIG. 1 according to one embodiment ofthe present invention. As shown in FIGS. 2A-2C, the outer tube 30 has aproximal section 55, a distal section 60 and an intermediate section 65between the proximal and distal sections 55, 60. As further shown, theproximal section 55 is fixedly disposed within the body 35 and extendsgenerally along a line parallel to a longitudinal axis 70 defined by thebody 35 and the plunger assembly 40.

In the illustrated embodiment, the intermediate section 65 includes aproximal curved portion 75 and a distal curved portion 80 having anopposite curvature to that of the proximal curved portion 75.Additionally, as shown, the distal section 60 also extends distally fromthe distal curved portion 80 along a line generally parallel to thelongitudinal axis 70. Accordingly, as can be seen in FIGS. 2A and 2B,the proximal and distal sections 55, 60 are laterally offset from oneanother by the intermediate section 65. In the illustrated embodiment,the proximal and distal sections 55, 60 are generally parallel to oneanother, although in other embodiments these sections may be angularlyoffset from one another as well.

As further shown, distal section 60 of the outer tube 30 terminates in asharpened, tissue-piercing distal tip 85 and includes a tissue stop 88.The distal tip 85 is configured to penetrate intervertebral disc tissue,in particular, the annulus fibrosus, for deployment of the implant 25,with the tissue stop 88 operating to delimit the depth of penetration ofthe outer tube 30 into the disc tissue. The tissue stop 88 attached tothe outer surface of the outer tube 30 and is located proximally apredetermined distance from the distal tip 85. In the illustratedembodiment, the tissue stop 88 includes a blunt distal face 90 and asloped proximal face 92, which is shaped to substantially prevent theproximal face 92 from catching on tissues when retracting the outer tube30 from the annulus fibrosus. In other embodiments, other structures(e.g., an enlarged diameter segment of the outer tube 30) suitable fordelimiting the penetration of the outer tube 30, are provided.

As shown and discussed in further detail below, laterally offsetting theproximal and distal sections 55, 60 of the outer tube 30 advantageouslyimproves the physician's visualization of the affected area of theannulus fibrosus to be repaired. That is, it allows the physician tomanipulate the implant delivery tool 30, and in particular, the body 35and the plunger assembly 40 without having his or her hands interferewith the line of sight to the aperture in the annulus fibrosus.

As further shown in FIGS. 2A-2C, the plunger assembly 40 includes aplunger member 100 and a pusher tube 105. As illustrated, the plungermember 100 includes a proximal knob 110 and a distal portion 115extending therefrom. Additionally, the distal portion 115 of the plungermember 100 is slidably and partially rotatably disposed within the body35. The pusher tube 105 is fixedly connected to and extends distallyfrom the distal portion 115 of the plunger member 100 within the outertube 30, terminating in a distal end 120. Accordingly, the pusher tube105 is also slidably and rotatably disposed within the outer tube 30.

The implant delivery tool 20 may, in many respects, have the samegeneral functionality as, for example, the fixation delivery apparatus400 described above and illustrated in FIGS. 48A-48E of co-pending andcommonly assigned U.S. Patent Publication No. 2009/0259260, thedisclosure of which is incorporated herein by reference in its entirety.Thus, the plunger assembly 40 is slidable relative to the body 35 andthe outer tube 30 to effectuate axial movement of the pusher tube 105for ejecting the implant 25 from the outer tube 30 into the desiredimplantation location within the disc annulus. In various embodiments,the implant delivery tool 20 further includes additional features thatallow the plunger member 100 and, in turn the pusher tube 105, to assumea plurality of discrete positions relative to outer tube 30 toselectively eject portions of the implant 25 therefrom.

For example, in various embodiments, the implant 25 includes two or moresoft tissue anchors 125 a, 125 b (shown in dashed lines in FIG. 2C)disposed in the distal section 60 of the outer tube 30 prior todeployment, with the distal end 120 of the pusher tube 105 positionedjust proximal to or abutting the proximal-most tissue anchor 125 a. Aswill be apparent from FIGS. 2A and 2C, by selectively advancing theplunger member 100 distally within the body 35 (after removing the tab42 from the distal portion 115 of the body member 100), the pusher tube105 is advanced a selected distance distally relative to the outer tube30, thereby ejecting the distal-most tissue anchor 125 b from the opendistal tip 85 of the outer tube 30, with the proximal-most tissue anchor125 a remaining in the outer tube 30. Subsequently, e.g., afterrelocating the distal tip 85 of the outer tube 30 to another location onan opposite side of the aperture in the annulus fibrosus to be repaired,the pusher tube 105 can be advanced distally a second distance to ejectthe proximal-most tissue anchor 125 a.

Thus, as can be seen in FIGS. 2A and 2B, the implant delivery tool 20includes additional features for facilitating advancement of the plungerassembly 40 in discrete steps selectively and sequentially ejectmultiple tissue anchors in series from the outer tube 30. For example,the implant delivery tool 20 includes an axial spring 150 in the body 35configured to bias the plunger assembly 40 in the proximal direction,and further includes a pin 155 biased radially inwardly by a lateralspring 160. The pin 155 is positioned to engage slots in the distalportion 115 of the plunger member 100 (described in further detailbelow) to control the distal movement of the plunger assembly 40relative to the body 35 and the outer tube 30. These features aresimilar or identical to corresponding features illustrated and describedwith respect to the fixation delivery apparatus 400 of FIGS. 48A-48E ofthe aforementioned U.S. Patent Publication 2009/0259260, and thus neednot be described in further detail here.

FIG. 3 is an elevation view of the plunger assembly 40 of the implantdelivery tool 20 according to one embodiment of the present invention.As shown in FIG. 3, the pusher tube 105 includes a flexible segment 200disposed between substantially rigid proximal and distal segments 205,210. As further shown, the proximal segment extends from the distalportion 115 of the plunger member 100, and the distal segment 210extends distally from the flexible segment 200 and terminates in thedistal end 120 of the pusher tube 105. In various other embodiments, theflexible segment 200 extends directly from the distal portion 115 of theplunger member 100, i.e., the rigid proximal segment 205 is omitted. Inother embodiments, the relatively rigid proximal segment 205 is presentand the relatively rigid distal segment 210 is omitted, and thus theflexible segment 200 extends from the proximal segment 205 to the distalend 120. In still other embodiments, the entire length of the pushertube 105 is flexible, and thus the pusher tube 105 includes no rigidproximal or distal segments 205, 210.

As further shown, the distal portion 115 of the plunger member 100includes one or more slots 220 shaped and positioned to be engaged bythe pin 155 (see FIG. 2A) for controlling the advancement of the plungerassembly 40, as described above and in the aforementioned U.S. PatentPublication No. 2009/0259260, which is incorporated herein by referencein its entirety.

The flexible segment 200 is configured to have a relatively high degreeof flexibility in response to laterally-applied forces (i.e., bendingforces) without significantly reducing the column strength of the pushertube 105. Additionally, the flexible segment 200 is positioned along thepusher tube 105 so that the intermediate section 65 of the pusher tube30 (see, e.g., FIGS. 2A and 2B) is axially coincident with the flexiblesegment 200 through the entire range of displacement of the pusher tube105 relative to the outer tube 30. That is, in various embodiments, theflexible segment 200 is dimensioned and positioned such that neither therigid proximal segment 205 (if present) nor the rigid distal segment 210of the pusher tube 105 will extend into the intermediate section 65 ofthe outer tube in any of the plurality of positions of pusher tube 105relative to the outer tube 30. Accordingly, the flexible segment 200 hasa predetermined length L which, in various embodiments, is selected tobe greater than the overall length of the intermediate section 65 of theouter tube 30. Thus, the flexible segment 200 of the pusher tube willsubstantially conform to the curved or non-linear shape of theintermediate section 65 of the outer tube 30 throughout the entire rangeof positions of the pusher tube 105.

Overall, the pusher tube 105 has a generally cylindrical tubularstructure, with the flexible segment 200 including features to impartthe desired degree of flexibility without significantly affecting thecolumn strength (i.e., resistance to buckling) of the pusher tube 200.In one embodiment, the pusher tube 105 has an outside diameter of about0.042 inches and an inside diameter of about 0.035 inches. In otherembodiments, the pusher tube 105 may have different inside and outsidediameters depending on the particular therapeutic needs for the repairdevice 10.

While not shown in FIGS. 2A-2C or FIG. 3, in various embodiments, theimplant delivery tool 20 may include additional support features withinthe body 35, the outer tube 30, and/or the plunger assembly 40 tosupport portions of the flexible segment 200 of the pusher tube 105. Forexample, in one embodiment, the body 35 or the outer tube 30 can includea sleeve (not shown) which extends proximally into the body 35 andslidably receives the proximal portions of the flexible segment 200. Inone embodiment, the distal portion 115 of the plunger member 100 caninclude a counterbore (also not shown) to receive the support sleeve onthe outer tube 30 and/or the body 35 as the plunger member 100 and thepusher tube 105 are advanced distally relative to the body 35 and theouter tube 30.

FIG. 4 is a schematic drawing illustrating one technique for impartinglateral flexibility to the flexible segment 200 of the pusher tube 105,according to one embodiment of the present invention. In the illustratedembodiment, the flexible segment 200 includes a slot 230 cut through thewall of the pusher tube 200 in a helical pattern around thecircumference of the pusher tube 200. As shown, the slot 230 has anundulating shape defining a series of keys 235. The slot 230 isdimensioned to allow a degree of freedom to allow the flexible segment200 to bend as the pusher tube 105 is advanced distally within the outertube 30. In one embodiment, the slot 230 is configured to have anaverage of about five keys 235 per rotation about the pusher tube 105.

In other embodiments, other techniques can be employed to impart thedesired flexibility in the flexible segment 200. For example, in variousembodiments, the slot 230 can have any of a number of shapes providingthe desired degree of freedom of movement in response to lateral (i.e.,bending) forces. In one embodiment, the slot 230 does not have anundulating shape, and thus takes on the configuration of a helicalspring (i.e., without defining any keys 235). In still otherembodiments, the flexible segment 200 can be heat treated to impartflexibility therein in addition to or in lieu of inclusion of the slot230. In short, any technique for imparting bending flexibility to theflexible segment 200 can be employed within the scope of the presentinvention.

While the plunger assembly 100 described above utilizes a tubular pushertube 105, in various other embodiments, the pusher tube 105 is replacedby a solid (i.e., non-tubular) pusher member, which may be made of ametallic or polymeric material selected to provide the requisiteflexibility and also sufficient column strength to avoid buckling.

FIGS. 5A-5C are schematic views of the implant 25 for use in the repairdevice 10 of FIG. 1 according to one embodiment of the presentinvention. As shown, the implant 25 includes the tissue anchors 125 a,125 b and adjustable flexible connecting element 300 connecting thetissue anchors 125 a, 125 b. As further shown, the implant 25 includes aretention line 301 coupled to the tissue anchor 125 a. In variousembodiments, the retention line 301 is provided to retain the tissueanchor 125 a within the outer tube 30 of the implant delivery tool 20during deployment of the distal tissue anchor 125 b, to preventundesired and premature ejection of the tissue anchor 125 a from theouter tube 30.

In various embodiments, the retention line 301 extends proximally withinthe pusher tube 105 of the plunger assembly 40 or within the outer tube30 and is connected to pusher tube 105, the plunger member 100, the body35, or some other feature at the proximal end of the implant deliverytool 20. Once the tissue anchor 125 a is deployed in the intervertebraldisc tissue, the physician can cut and remove the retention line 301from the implant 25. In other embodiments, the retention line 301 isconfigured to be automatically cut by and removed with the delivery tool20 after deployment of the tissue anchor 125 a, thus eliminating theneed for a separate cutting step. In various other embodiments, theretention line 301 is omitted, and a different technique is employed toretain the tissue anchor 125 a in the outer tube 30 prior to itsintended deployment. For example, in one embodiment, the distal end 120of the pusher tube 105 can include a hook or other feature to engage aknot or similar feature on the implant 25, and this engagement operatesto retain the tissue anchor 125 a in the outer tube 30. In still otherembodiments, however, the functionality of the retention line 301 isomitted.

In the illustrated embodiment, the connecting element 300 is a knotlesssuture construct formed at least partially or wholly from a tubular,braided suture material and includes a distal segment 302, anintermediate segment 304 extending proximally from the distal segment302, and a proximal segment 306 extending proximally from theintermediate segment 304 to form the tension line 50 (see FIG. 1).

As further shown, the intermediate segment 304 includes an adjustableloop 310 and a locking element 315 having a proximal end 317 and adistal end 318. As shown, the tissue anchor 125 a is slidably coupled tothe adjustable loop 310, and the tissue anchor 125 b extends from thelocking element 315, which is interposed between the tissue anchors 125a and 125 b. As can be seen in FIG. 5C, the tissue anchor 125 a iscoupled to the adjustable loop 310 by a suture loop 320 extendingthrough the tissue anchor 125 a and secured thereto by a knot 325, thusallowing the tissue anchor 125 a to slide along the length of thebraided suture material of the adjustable loop 310. Additionally, thedistal segment 302 extends through the tissue anchor 125 b and issecured thereto by a locking arrangement 330, which in the illustratedembodiment is a knotted loop, and then extends proximally along a fixedlength to the locking element 315. In various embodiments, the distalsegment 302 may include only a single strand of suture material, and thelocking element 330 is a knot, pledget, or similar structure whichprevents the distal segment 302 from being pulled through and detachedfrom the tissue anchor 125 b.

In the illustrated embodiment, the connecting element 300 is formed byforming the adjustable loop 310 with the braided suture material of theintermediate segment 304, and then running the suture material backthrough an outer wall of a length of the braided suture material to formthe locking element 315 in the form of a tubular braided catch. That is,a length of the intermediate segment 304 is inserted through the outersuture wall and into the interior of the braided suture material at theproximal end 317 of the locking element 315, then exits the braidedsuture material at the distal end 318 of the locking element 315, andthereafter extends proximally to form the proximal segment 306 and thetension line 50.

In this configuration, when tension is applied between the tension line50 and the tissue anchor 125 a and/or 125 b, the overall length of theadjustable loop 310 is reduced thus reducing the separation between thetissue anchors 125 a and 125 b. As can be seen from FIGS. 5A and 5C, asthe length of the adjustable loop 310 is reduced, the suture loop 320allows the tissue anchor 125 a to slide along the adjustable loop 310.The braided locking element 315 radially constricts the portion of theintermediate segment 304 extending internally therein, operating toprevent reverse movement of the suture material of the intermediatesegment 304 extending within the locking element 315. Thus, once theadjustable loop 310 is shortened, the locking element 315 will preventsubsequent elongation of the adjustable loop 310.

In the illustrated embodiment, the adjustable connecting element 300 isformed from a single, continuous length of braided suture material.However, in other embodiments, the connecting element 300 is formed fromdifferent materials coupled together to form the various components ofthereof. For example, in one embodiment, the locking element 315 is aseparate braided tube disposed over the suture material forming theother components of the connecting element 300.

Thus, in use, the tissue anchor 125 b is first ejected from the outertube 30 of the implant delivery tool 20 and into or through the annulusfibrosus, as discussed above. Subsequently, the outer tube 30 is removedfrom the annulus fibrosus and re-inserted at a different location (e.g.,on an opposite side of the aperture to be repaired) and the tissueanchor 125 a is then ejected into the annulus fibrosus. As explainedabove, the retention line 301, if present, operates to retain the tissueanchor 125 a in the outer tube 30 during deployment of the tissue anchor125 b and subsequent repositioning of the implant delivery tool 20.After deployment of the tissue anchor 125 a, the retention line 301 canbe wholly or partially removed, e.g., by cutting the retention lineproximate the tissue anchor 125 a.

The physician can then apply tension to the tension line 50, which willbe resisted by the tissue anchor 125 a and/or 125 b bearing against theannulus fibrosus tissue. With the tissue anchors 125 a, 125 beffectively secured in place against the annulus fibrosus, the tensionline 50 can be pulled through the locking element 315 to shorten thelength of the adjustable loop 310 between the tissue anchors 125 a, 125b. In this way, once both tissue anchors 125 a and 125 b bear againstthe annulus fibrosus tissue, the tissues defining the aperture can bepulled toward one another under tension by further reducing the lengthof the adjustable loop between the tissue anchors 125 a, 125 b, therebyat least partially or wholly closing the aperture. The design of thelocking element 315, as discussed above, substantially preventssubsequent reverse movement of the tension line through the lockingelement 315, thus maintaining the adjustable loop 310 in tension betweenthe tissue anchors 125 a and 125 b. Any excess length of the tensionline 50 can subsequently be cut away to complete the implantationprocedure.

FIGS. 6A-6C are schematic views of an alternative implant 400 for use inthe repair device 10 according to one embodiment of the presentinvention. As shown in FIGS. 6A-6C, the implant 400 includes a pair oftissue anchors 425 a, 425 b, an adjustable flexible connecting element427 connecting the tissue anchors 425 a, 425 b, and a retention line428. In the illustrated embodiment, the connecting element 427 is aknotless suture construct formed at least partially or wholly from atubular, braided suture material and includes a distal segment 428, anintermediate segment 430 and a proximal segment 431.

As further shown, the intermediate segment 430 includes an adjustableloop 432, a locking element 435 having a proximal end 436 and a distalend 437, and the proximal segment 431 forms a tension line 440. Theretention line 428, the locking element 435 and the tension line 440may, in various embodiments, be configured in substantially the samemanner as the retention line 301, the locking element 315 and thetension line 50 described above with respect to the implant 25, and arethus not described in further detail again here.

As shown, the tissue anchor 425 a is slidably coupled to the adjustableloop 432, and the tissue anchor 425 b is fixedly connected to thelocking element 435, which is interposed between the tissue anchors 425a and 425 b. As can be seen in FIG. 6C, the tissue anchor 425 a iscoupled to the adjustable loop 430 by a suture loop 442 extendingthrough the tissue anchor 425 a and secured thereto by a knot 445.Additionally, the tissue anchor 425 b is fixedly attached to the distalsegment 428 by a knot 450, and the distal segment 428 extends proximallyalong a fixed length to the locking element 435.

In the illustrated embodiment, the connecting element 427 is formed byforming the adjustable loop 432 with the braided suture material of theintermediate segment 430, and then running the suture material backthrough an outer wall of the braided suture material to form the lockingelement 435 in the form of a tubular braided catch. That is, a length ofthe intermediate segment 430 is inserted through the outer suture walland into the interior of the braided suture material at the distal end437 of the locking element 435, and then exits the braided suturematerial at the proximal end 436 of the locking element 435, thereafterextending proximally to form the proximal segment 431 and the tensionline 440. In this configuration, when tension is applied between thetension line 440 and the tissue anchor 425 b, the overall length of theadjustable loop 432 is reduced thus reducing the separation between thetissue anchors 425 a and 425 b. As can be seen from FIGS. 6A and 6C, asthe length of the adjustable loop 432 is reduced, the suture loop 442allows the tissue anchor 425 a to slide along the adjustable loop 432.However, once the adjustable loop 432 is shortened, the locking element435 will prevent subsequent elongation of the adjustable loop 432.

Prior to deployment, the tissue anchor 425 a is disposed within theouter tube 30 of the implant delivery tool 20 proximal to the tissueanchor 425 b. In the illustrated embodiment, the connecting element 427further includes a resistance feature 460 on the tension line 440proximal to the locking element 435, which is positioned inside theouter tube 30 prior to and during deployment of the tissue anchors 425a, 425 b to encourage toggling/rotation of the tissue anchors 425 a, 425b as they are ejected from the outer tube 30. In the illustratedembodiment, the resistance feature 460 is in the form of a knotdimensioned to contact the inner surface of the outer tube 30. Invarious other embodiments, the resistance feature can take on adifferent form (e.g., a resilient sphere or cylinder disposed over theconnecting element 427 suture material), or may be eliminatedaltogether.

In use, the implant 400 operates in much the same manner as the implant25 described above. That is, the tissue anchor 425 b is first ejectedfrom the outer tube 30 of the implant delivery tool 20 and into orthrough the annulus fibrosus, as discussed above. Subsequently, theouter tube 30 is removed from the annulus fibrosus and re-inserted at adifferent location (e.g., on an opposite side of the aperture to berepaired) and the tissue anchor 425 a is then ejected into the annulusfibrosus. The retention line 428, if present, operates to retain thetissue anchor 425 a in the outer tube 30 during deployment of the tissueanchor 425 b and repositioning of the implant delivery instrument 20.The physician can then apply tension to the tension line 440, which willbe resisted by the tissue anchor 425 a and/or 425 b bearing against theannulus fibrosus tissue. With the tissue anchors 425 a, 425 beffectively secured in place against the annulus fibrosus, the tensionline 440 can be pulled through the locking element 435 to shorten thelength of the adjustable loop 432 between the tissue anchors 425 a, 425b. In this way, once both tissue anchors 425 a and 425 b bear againstthe annulus fibrosus tissue, the tissues defining the aperture can bepulled toward one another under tension by further reducing the lengthof the adjustable loop between the tissue anchors 425 a, 425 b, therebyat least partially or wholly closing the aperture. The design of thelocking element 435, as discussed above, substantially preventssubsequent reverse movement of the tension line through the lockingelement 435, thus maintaining the adjustable loop 430 in tension betweenthe tissue anchors 425 a and 425 b. Any excess length of the tensionline 440 can subsequently be cut away to complete the implantationprocedure.

Although the implants 25, 400 described above include knotlessconnecting elements 300, 427, this is not a requirement. Thus, invarious embodiments, the knotless locking elements of the respectiveimplants can be replaced by knots, e.g., Roeder knots, Weston knots, orsimilar constructs, by pledgets, or by other structures allowing forshortening the length of the connecting element portion between thetissue anchors while resisting or preventing subsequent elongationthereof. In sort, any technique for providing the requisite lengthadjustment capability in the connecting elements 300, 427 can beemployed within the scope of the present invention.

In various embodiments, two repair devices 10 can be provided, e.g., asin an annulus fibrosus repair system, for deployment of two implants 25or 400 to effectuate re-approximation of an aperture in the annulusfibrosus. In one embodiment, the two implants 25 or 400 can be deployedin a manner such that the portions of the respective adjustableconnecting elements spanning across the aperture external to the outsidesurface of the annulus fibrosus cross each other, in the form of an “X.”This construct advantageously provides multi-location contact betweenthe respective tissue anchors and connecting elements to effectivelydraw together the tissues defining the aperture in the annulus fibrosus.

In still other embodiments, the repair device 10 can be used to secureanother implant, e.g., an occlusion device, to an implantation withinthe annulus fibrosus to occlude an aperture therein. This can be inaddition to or in lieu of partially or wholly closing the apertureitself using the repair device 10. For example, in one embodiment, anexpandable occlusion device can be implanted within the intervertebraldisc so as to span across the aperture in the annulus fibrosus, and oneor more implants 25, 400 can then be implanted into or through both theannulus fibrosus tissue and the occlusion device to secure the occlusiondevice in place. Exemplary occlusion devices that can be used in thismanner are described and illustrated in co-pending and commonly assignedU.S. Patent Publication No. 2005/0283246, the disclosure of which isincorporated herein by reference. In other embodiments, a patchingelement can be positioned on the exterior surface of the annulusfibrosus and secured in place using the implants 25 and/or 400.

While the tissue anchors 125 a/b and 425 a/b illustrated above are shownand described as T-anchors, in various embodiments, these tissue anchorscan take on any number of forms providing the desired degree of tissuecontact and engagement with the annulus fibrosus. In variousembodiments, the tissue anchors 125 a/b and/or 424 a/b can beconstructed to be configured such as the T-anchors 815 shown in FIG. 69and/or the T-anchors 951 a/b in FIGS. 70, 71A-B, 72 and 73 of theaforementioned co-pending and commonly assigned U.S. Patent Publication2009/0259260, which is incorporated herein by reference in its entirety.

The materials used in the implant delivery tool 20 or the implants 25,400 can include any number of biocompatible materials having suitablemechanical properties. Materials of which to make the outer tube 30and/or the push tube 105 of the implant delivery tool 20 and also thetissue anchors 125 a/b and/or 435 a/b of the implants 25, 400 caninclude, but are not limited to: metals, such as stainless steel,nickel, titanium alloy, and titanium; plastics, such aspolytetrafluoroethylene (PTFE), polypropylene, polyether etherketone(PEEK™), polyethylene, polyethylene teraphthalate (PET) andpolyurethane, acrylic, polycarbonate, engineering plastics; and/orcomposites. The adjustable connecting elements 300, 427 can likewise bemade of any suitable suture material. In various embodiments, theconnecting elements 300, 427 are made wholly or partially of size 2-0 or3-0 force fiber suture material. In short, any suitable materials,whether now known or later developed, can be utilized to construct theimplant delivery tool 20 and the implants 25, 400, within the scope ofthe present invention.

FIG. 7 illustrates an alternative device 480 for use in repairing anaperture or a defect in an annulus fibrosus of an intervertebral discutilizing the implants 25, 400 according to an embodiment of the presentinvention. The device 480 includes an implant delivery tool 482 and animplant 25 or 4000 as described above. The implant delivery tool 482 is,except as noted below, substantially the same or identical in structureand function to the implant delivery tool 20 described above.Accordingly, as shown in FIG. 7, the implant delivery tool 482 andincludes an a substantially rigid outer tube 483 having a proximalsection 484 and a sharpened distal tip 485, a body 486 coupled to theproximal section 484 of the outer tube 483, and a plunger assembly 488movable axially relative to the body 486. The plunger assembly 488 alsoincludes plunger member 489 and a pusher tube (not shown in FIG. 7coupled thereto and disposed within the outer tube 483. The implantdelivery tool 482 differs from the implant delivery tool 20 in that therigid outer tube 483 is generally straight, and does not include theoffset intermediate section of the outer tube 30 of the implant deliverytool 20. Accordingly, in various embodiments, the implant delivery tool482 is functionally and structurally similar to the fixation deliveryapparatus 400 of FIGS. 48A-48E of the aforementioned U.S. PatentPublication 2009/0259260, which is incorporated herein by reference inits entirety.

FIGS. 8A-8C are schematic illustrations showing the annulus fibrosusrepair device 10 of FIG. 1 in use during a repair procedure on anannulus fibrosus 500, and in particular, a procedure to re-approximatetissues defining an aperture 505 in the annulus fibrosus 500. As shownin FIG. 8A, in use, the distal section 60 of the outer tube 30 of theimplant delivery tool 20 is partially inserted into or through theannulus fibrosus 500 near the aperture 505 for deploying the tissueanchor 125 b (not shown in FIG. 8A) from the distal tip 85 of the outertube 30. As further illustrated, because the offset in the outer tube 30maintains a clear line of site to the implantation location, withoutvisual interference by the body 35 of the implant delivery tool 20, andconsequently, the physician's own hands.

As can be seen in FIG. 8B, after deployment of the tissue anchor 125 b,the implant delivery tool 20 is subsequently removed and reinserted intoor through the tissue of the annulus fibrosus 500 at a second locationon the opposite side of the aperture 505. As shown, a portion of theadjustable connecting element 300 extends across the aperture 505external to the outer surface of the annulus fibrosus. Again, as can beseen in FIGS. 8A and 8B, during insertion of the distal tip 85 of theouter tube 30 of the implant delivery tool 20 into the annulus fibrosus500 proximate the aperture 505, the offset configuration of the outertube 30 results in the body 35 of the implant delivery tool 20 beingremoved from physician's line of sight to the repair site.

Subsequently, as shown in FIG. 8C, after deployment of the tissue anchor125 a and removal of the implant delivery tool 20 from the tissue of theannulus fibrosus 500, the tension line 50 is pulled to shorten thelength of the adjustable connecting element 300 between the tissueanchors 125 a, 125 b, thereby pulling together and re-approximating thetissues defining the aperture 500. While not shown in FIG. 8C, excesslength of the tension line 50 can then be removed.

In various embodiments, multiple devices 10 each including an implantdelivery tool 20 and an implant 25 or 400 can be utilized as a systemfor intervertebral disc annulus repair. For example, in variousembodiments, after deploying the first implant 25 and at least partiallyre-approximating tissues defining the aperture 500 as shown in FIG. 8C,a second device 10 can be utilized to deploy a second implant 25 tofurther re-approximate the defect and/or to augment or reinforce thepreviously implanted implant 25. In such embodiments, the second implant25 may be deployed using the same or similar techniques illustrated inFIGS. 8A-8C, with each tissue anchor 125 a, 125 b of the second implant25 being inserted into the annulus at different locations such that theadjustable connecting element 300 spans across the defect. The length ofthe adjustable connecting element 300 of the second implant 25 can thenbe shortened to complete the re-approximation procedure. Of course, theimplant 400 could be utilized in place of the implant 25 in any of theforegoing procedures.

FIGS. 9A-9C are plan and cut-away elevation views of an implant deliverytool 600 with an implant 610 coupled thereto according to anotherembodiment of the present invention. As shown in FIGS. 9A-9C, thedelivery tool 600 includes a body 612 including a proximal handle 616and an outer tubular member 620 extending distally from the handle 616and having an open distal end 624. As further shown, the delivery tool600 has a needle cannula 628, a pusher member 634, and an actuatingmechanism 640. In the illustrated embodiment, the needle cannula 628 isslidably received within the outer tubular member 620, and the pushermember 634 is slidably received within the needle cannula 628.Additionally, the actuating mechanism 640 includes a lever 646 pivotallycoupled to the handle 616, and a releasable safety tab 648 is connectedto a portion of the implant 610 and to the inner pusher member 634. Aswill be explained and illustrated in further detail below, the lever 646is configured to engage the needle cannula 628 for selectively adjustingthe axial position of the needle cannula 628 relative to the pushermember 634 and the outer tubular member 620. In addition, the safety tab648 is coupled to the pusher member 634 and is operable to preventunintended, spontaneous axial movement of the needle cannula 628 and thepusher member 634 relative to the outer tubular member 620, as well asto assist the clinician in deploying the implant 610.

As further shown, in the pre-deployed state of FIGS. 9A-9C, the implant610 is disposed within the needle cannula 628 and includes an anchormember 650 and an adjustable suture assembly 654. In the illustratedembodiment, the adjustable suture assembly 654 is connected to theanchor member 650 and also to the delivery tool 600, as will beexplained in further detail below. In various embodiments, the anchormember 650 is configured to be implanted within a vertebra or softtissue of the patient's spine, and the adjustable suture assembly 654 isconfigured to be interconnected to a second implant and placed undertension so as to repair a defect or aperture in the annulus fibrosus.Thus, the implant 610 can, in various embodiments, be used tore-approximate an aperture in the annulus fibrosus in the same manner asthe systems disclosed in co-pending and commonly assigned U.S.application Ser. Nos. 12/251,295 and 12/553,583, the entire disclosuresof which are incorporated herein by reference in their entireties.

The delivery tool 600 is configured to be operated by a clinician todeploy the anchor member 650 into the vertebra and to facilitatetensioning the adjustable suture assembly 654 for repairing the annulardefect. In various embodiments, the delivery tool 600 is configured suchthat, prior to deployment of the anchor member 650, the needle cannula628 and the pusher member 634 are disposed within the outer tubularmember 620, as is shown in FIG. 9A. Additionally, the needle cannula 628and the pusher member 634 can be advanced distally together relative tothe outer tubular member 620, e.g., to penetrate a vertebral body withthe tip of the needle cannula 628 for insertion of the anchor member 650into the vertebral body, and the needle cannula 628 can subsequently beretracted proximally while the pusher member 634 remains stationary,thereby releasing the anchor member 650 from the needle cannula 628 intothe vertebra. The delivery tool 600 advantageously facilitatesdeployment of the anchor member 650 into the vertebra without requiringfirst drilling or otherwise forming a hole in the vertebra (e.g., with abone awl) to receive the anchor member 650.

FIGS. 10A-10C are plan and cross-sectional elevation views of the body612 of the delivery tool 600 according to one embodiment of the presentinvention. As shown in FIGS. 10A-10C, the handle 616 includes a tubularupper portion 660 having a proximal end 662 and a distal end 663, and alower portion 664 extending from the upper portion 660. As furthershown, the outer tubular member 620 extends distally from the distal end663 of the handle upper portion 660, and the handle upper portion 660 isgenerally aligned with the tubular outer member 620 of the delivery tool600 so as to define a longitudinal axis 666 of the delivery tool 600.The lower portion 664 of the handle is adapted to be gripped by theclinician during use of the delivery tool 600. In the illustratedembodiment, the lower portion 664 extends generally orthogonal to theupper portion 660 and the longitudinal axis 666, although in otherembodiments, the lower portion 664 may extend from the upper portion 660at an oblique angle.

As further shown, in FIG. 10C, the upper portion 660 of the handle 616includes an upper slot 670 and a lower slot 674 disposed generally 180degrees from the upper slot 670. In the illustrated embodiment, theupper and lower slots 670, 674 are located between the proximal anddistal ends 662, 663. Additionally, the upper slot 670 has a generallyconstant width along its length. In contrast, in the illustratedembodiment, the lower slot 674 has a rear segment 676 having a firstwidth Wr (see FIG. 10C) and a forward segment 678 having second width Wf(see FIG. 10C). In the illustrated embodiment, Wf is greater than Wr soas to define a shoulder 182 at the transition between the rear andforward segments 676, 678. Additionally, as further shown, a projection686 extends distally from the shoulder 682, forming a recess 688.

As will be explained in further detail below, upper and lower slots 670,674 are dimensioned and configured to slidingly receive and guidestructures on the needle cannula 628 and pusher member 634,respectively. Additionally, the recess 688 is sized to receive astructure (shown in dashed lines in FIG. 10C) on the inner pusher member634 such that the projection 686 operates as a rotation stop preventingunintentional rotation of the pusher member 634.

As further shown, in the illustrated embodiment, the outer tubularmember 620 includes a slot 692 extending proximally from the open distalend 624. The slot 692 provides means by which portions of the adjustablesuture assembly 654 can extend from within the needle cannula 628 (seeFIG. 9C).

FIGS. 11A-11C are plan and elevation views of the needle cannula 628 ofthe delivery tool 610 according to one embodiment of the presentinvention. As shown, the needle cannula 628 has a proximal portion 696with a proximal end 698, and an open distal end 704 terminating in asharpened distal tip 708. In the illustrated embodiment, the proximalportion 696 includes a flange 718 and a pair of diametrically disposedslots 722, 726 extending distally from the proximal end 698. In theillustrated embodiment, the flange 718 includes an aperture 730 forattaching a portion of the adjustable suture assembly 654 of the implant610, as explained further below. The needle cannula 628 is dimensionedto be slidingly received within the outer tubular member 620, and theflange 718 is dimensioned to be slidingly received within the upper slot670 in the upper portion 660 of the handle 616. Thus, when assembled,the flange 718 extends from and slides axially within the upper slot670, which further operates to prevent rotation of the needle cannula628.

In the illustrated embodiment the proximal portion 696 of the needlecannula 628 includes sleeve structure fixedly attached to a tubularneedle. In various other embodiments, the needle cannula 628 can beconfigured to include the flange 718 and slots 722, 726 as integralfeatures of the tubular needle.

As shown, the slots 722, 726 are radially offset from the flange 718.The slots 722, 726 have widths selected to slidingly receive structureson the pusher member 634 to allow relative axial movement but preventrelative rotation of the needle cannula 628 and the pusher member 634when aligned. At the same time, the proximal portion 696 is configuredto engage structures on the pusher member 634 when not aligned so as toprevent relative axial movement of the needle cannula 628 and the pushermember 634.

As further shown, the needle cannula 628 further includes a slot 736adjacent to the open distal end 704. In the illustrated embodiment, theslot 736 is radially aligned with the flange 718, and when assembledwith the handle 616 and the outer tubular member 620, with the slot 692in the outer tubular member 620. Thus, the slots 692 and 736 bothoperate to allow portions of the implant adjustable suture assembly 654to extend from the needle cannula 628.

FIG. 12 is an elevation view of the pusher member 634 of the deliverytool 600 according to one embodiment of the present invention. As shownin FIG. 12, the pusher member 634 has a proximal end 740 and a bluntdistal end 744. As further shown, at the proximal end 740 is an endplate 746. The pusher member 634 further includes a radially extendingtab 748, and a radially extending projection 754 disposed diametricallyopposite the tab 748. When assembled, the pusher member 634 and theneedle cannula 628 are configured so that the tab 748 and the projection754 engage the proximal portion 696 of the needle cannula 628 when notaligned with the slots 722, 726, thereby preventing axial movement ofthe pusher member 634 relative to the needle cannula 628. In turn, whenthe tab 748 and the projection 754 of the pusher member 634 are alignedwith the slots 722, 726, the needle cannula 628 can be retracted axiallyrelative to the pusher member 634, which facilitates deployment of theanchor member 650 into the patient's vertebra.

Additionally, the handle 616, the needle cannula 628 and the pushermember 634 are further configured such that, when assembled, the tab 748can be received within the recess 688 in the upper portion 660 of thehandle 616 (see FIG. 10C), and at the same time aligned with the slot726 in the needle cannula proximal portion 696. In this configuration,the projection 686 of the handle upper portion 660 prevents rotation ofthe pusher member 634 to maintain alignment of the tab 748 and the slot726 during retraction of the needle cannula 628.

As further shown in FIG. 12, the end plate 746 extends radially relativeto the pusher member 634. The end plate 746 facilitates driving theneedle cannula 628 and the pusher member 634 disposed therein into thepatient's vertebra (e.g., providing a bearing surface that can be tappedusing a mallet).

The needle cannula 628 and the pusher member 634 are each dimensionedsuch that they can extend distally a desired distance (e.g., based onthe desired depth of deployment of the anchor member 650 into thevertebra) beyond the distal end 624 of the outer tubular member 620 whenfully advanced. Additionally, the pusher member 634 as a whole is longerthan the needle cannula 628 (including the proximal portion 696), suchthat the distal end 744 of the pusher member 634 extends distally beyondboth the distal end 704 of the needle cannula 628 and the distal end 624of the outer tubular member 620 when the needle cannula 628 is retractedproximally relative to the pusher member 634.

FIG. 13 is a schematic illustration of the implant 610 showing detailsof the anchor member 650 and the adjustable suture assembly 654according to one embodiment of the present invention. As shown in FIG.13, the suture assembly 654 includes a tension line 760 forming a loop762, a toggle line 766 and a connecting segment 770. As further shown,the anchor member 650 has opposed beveled ends 774, 776 and a channel780 extending through the anchor member 650 generally orthogonally tothe major length of the anchor member 650. In the illustratedembodiment, the channel 780 is located nearer to the beveled end 774than the beveled end 776 which, as explained further below, facilitatestoggling of the anchor member 650 during deployment to promote goodengagement with the bone (e.g., vertebra) or other tissue in which theanchor member 650 is implanted.

As shown in FIG. 13, the connecting segment 770 extends through thechannel 780 and is fixedly connected to the anchor member 650. Asfurther shown, the tension line 760 extends from the connecting segment280 and has a free end 284 and a locking element 288 which itself hasfirst and second ends 294, 298. As shown, the locking element 288 islocated between the free end 284 and the adjustable loop 762. In theillustrated embodiment, the tension line 760 including the lockingelement 288 is a knotless suture construct formed at least wholly orpartially from a tubular, braided suture material to facilitateselective adjustment of the overall dimensions of the loop 762. Thus, asshown, the suture material of the tension line 262 enters the interiorof the tubular suture material at the first end 294 of the lockingelement 288 and exits the interior of the tubular suture material at thesecond end 298 of the locking element 288, thereafter extending to thefree end 284. As explained in further detail below, the free end 284 isconnected to the safety tab 648 of the delivery tool 600, and can bemanipulated by the clinician to reduce the dimensions of the loop 762during an annular repair procedure.

In use, when tension is applied to the tension line 760 while the anchormember 650 is embedded in the patient's vertebra (or other tissue), theoverall dimensions of the adjustable loop 762 are reduced. The braidedlocking element 288 allows the tension line 760 to move within thelocking element 288 in the direction of the tensile force, while at thesame time radially constricts the portion of the tension line 760extending internally therein to prevent reverse movement of the tensionline 760. Thus, once the dimensions of the adjustable loop 762 arereduced, the locking element 288 will prevent subsequent enlargement ofthe adjustable loop 288. Thus, the tension loop 260 is in many respectssimilar or identical to the knotless suture construct of the implants25, 400 described above. In other embodiments, however, the tension line760 with locking element 288 is not a knotless construct, but insteadutilizes a knot (e.g., a Roeder knot or a Weston knot) or other means tofacilitate one-way adjustment of the dimensions of the loop 762.

As further shown in FIG. 13, the toggle line 766 is attached to theconnecting segment 770 and has ends 302, 304 which, as explained infurther detail below, are tied together and connected to the flange 718of the needle cannula 628 (see FIG. 9A). In one embodiment, the toggleline 766 is attached to the connecting segment 770 by one or more knotsor other means to prevent sliding movement of the toggle line 766relative to the connecting segment 770. Thus, tension applied to thetoggle line 766 during operation of the delivery tool 600 is transferreddirectly to the connecting segment 770. In this way, because theconnecting segment 770 is not centered on the anchor member 650 (due tothe fact that the channel 780 is offset from the center of the anchormember), the anchor member 650 will tend to rotate when tension isapplied to the toggle line 766, thus promoting engagement of the anchormember 650 to the bone or tissue in which it is implanted. In oneembodiment, the toggle line 766 is configured to have a pre-determinedbreaking point, e.g., near the location at which it is attached to theconnecting segment 770, such that the toggle line 766 will automaticallybreak during actuation of the delivery tool 600. In such embodiments,the need to separately cut away the toggle line 766 after deployment ofthe anchor member 650 is avoided.

In other embodiments, however, the toggle line 766 is not designed toautomatically break during actuation of the delivery tool 600. Forexample, in various embodiments, the toggle line 766 remains attached tothe connecting segment 770 (or other component of the suture assembly654) after complete deployment of the anchor member 650. In suchembodiments, the toggle line 766 can be used by the clinician to ensurepositive engagement of the anchor member 650 to the bone or other tissuein which it is deployed, e.g., by pulling on the toggle line 766 afterdeployment of the anchor member 650. In these embodiments, the toggleline 766 can thereafter be separately be cut away from the sutureassembly 654.

Returning to FIGS. 9A-9C, in the assembled and pre-deployedconfiguration, the needle cannula 628 is disposed within the outertubular member 620, and the proximal portion 696 being disposed withinthe upper portion 660 of the handle 616 with the flange 718 of theproximal portion 696 disposed in and extending outward from the upperslot 670. As further shown, the pusher member 634 is partially disposedwithin the needle cannula 628 and the upper portion 660 of the handle616, with the proximal end 740, including the end plate 746, of thepusher member 634 extending proximally from the proximal end 662 of thehandle upper portion 660. Additionally, the needle cannula 628 and thepusher member 634 are generally aligned with the longitudinal axis 166.

In the pre-deployed configuration shown, the tab 748 of the pushermember 634 is positioned in the rear segment 676 of the lower slot 674in the handle upper portion 660. As explained above, the width Wr of therear slot segment 676 is selected to substantially prevent rotation ofthe pusher member 634 relative to the handle 616 when so positioned. Asfurther shown, the tab 748 and the projection 754 of the pusher member634 are not radially aligned with the slots 722, 726 of the needlecannula proximal portion 696, but rather, abut and bear against theproximal portion 696. Accordingly, in this configuration, by urging thepusher member 634 axially in the distal direction relative to the handle616 will also cause the needle cannula 628 to move with the pushermember 634. In the pre-deployed configuration shown, however, the safetytab 648 is releasably coupled (e.g., clipped or snapped over) the pushermember 634 and abuts the end plate 746 on one end and the proximal end662 of the handle upper member 660 on the opposing end. Accordingly, thesafety tab 648 prevents unintended axial movement of the pusher member634 relative to the handle 616. It will be appreciated, however, thatremoval of the safety tab 648 from the pusher member 634 will allow thepusher member 634 and the needle cannula 628 to be advanced distallyrelative to the handle 616 and the outer tubular member 620.

As further shown in FIG. 9B, the lever 646 is pivotally connected to thelower portion 664 of the handle 616 at a pivot point 810, and itselfincludes an upper portion 816, a lower portion 820, and a resilientmember 826 extending from the lower portion 820. In the illustratedembodiment, the upper portion 816 is disposed within the interior of thehandle 616 and is shaped to engage the proximal portion 696 of theneedle cannula 628. Additionally, the lower portion 820 partiallyextends from the handle lower portion 664, and the resilient member 826bears against a wall 830 of the handle 616 interior. Thus, when thelower portion 820 of the lever 646 is urged into the handle lowerportion 664, the upper portion 816, which is engaged with the proximalportion 696 of the needle cannula 628, will tend to urge the needlecannula 628 proximally relative to the handle 616. As will beappreciated, however, in the pre-deployed configuration shown, suchproximal movement of the needle cannula 628 is prevented by the tab 748of the pusher member 634, which is captured within the rear segment 676of the lower slot 674 in the handle upper portion 660. The resilientmember 826 operates to bias the lower portion 820 of the lever 646 awayfrom the handle 616, thereby enhancing the tactile feel and control ofthe operation of the lever 646 by the clinician. In various embodiments,a spring or other biasing element can be utilized in lieu of or inaddition to the resilient member 826, or alternatively, this biasingfunction can be eliminated altogether.

As can perhaps be best seen in FIG. 9C, the anchor member 650 isdisposed within the needle cannula 628 proximate the open distal end704, with the distal end 744 of the pusher member 634 abutting theanchor member 650. As further shown, the adjustable suture assembly 654extends outward of the delivery tool 600 through the slots 692 and 736in the outer tubular member 620 and the needle cannula 628,respectively. As shown in FIG. 9B, the toggle line 766 extends externalto the delivery tool 600 and is connected to the flange 718 on theneedle cannula proximal portion 696. In the pre-deployed configurationshown, the toggle line 766 operates, at least in part, to prevent theanchor member 650 from unintentionally being ejected from the deliverytool 600.

Additionally, the tension line 760 extends external to the delivery tool600 and is connected to the safety tab 648. As further shown in FIGS. 9Aand 9B, the delivery tool 600 also includes a suture management element836, which in the illustrated embodiment is an elastic band or sleevedisposed about the outer tubular member 620 near its distal end 624. Thesuture management element 836 operates to releasably retain portions ofthe suture assembly 654 against the outer tubular member 620 prior toand during deployment of the implant 110, similar or identical to theelastic band (473) described in co-pending and commonly assigned U.S.application Ser. No. 12/553,583, which is incorporated herein byreference.

FIGS. 14A-14E are partial cut-away elevation views of the implantdelivery tool 600 during use to deploy the implant 610 partially withina vertebral body 900 of a patient. As shown in FIG. 14A, the deliverytool 600 is initially positioned with the distal end 624 of the outertubular member 620 abutting the surface of the vertebral body 900 at thedesired implantation location for the anchor member 650 (not shown inFIG. 14A). In this configuration, as explained above, the tab 748 of thepusher member 634 is positioned in the rear segment 676 of the lowerslot 674 in the handle upper portion 660, and the tab 748 and theprojection 754 of the pusher member 634 are not radially aligned withthe slots 722, 726 of the needle cannula proximal portion 696, butrather, abut and bear against the proximal portion 696.

Then, as shown in FIG. 14B, the safety tab 648 is removed from thepusher member 634 and set aside, and the needle cannula 628 (with theanchor member 650 disposed therein) and the pusher member 634 areadvanced distally so as to drive the sharpened distal tip 708 of theneedle cannula into the vertebral body 900. In various embodiments, forexample, a mallet can be used to tap against the end plate 746 of thepusher member 634. Because the tab 748 and the projection 754 of thepusher member 634 abut and bear against the proximal portion 696 of theneedle cannula 628, distal movement of the pusher member 634 also movesthe needle cannula 628 distally relative to the handle 616 and the outertubular member 620 a desired distance into the vertebral body 900.

The pusher member 634 and other elements of the delivery tool 600 are,in various embodiments, dimensioned to provide a sufficient depth ofpenetration of the needle cannula 628 into the bone to facilitatedeployment of the anchor member 650 and also encourage strong engagementwith the bone. For example, in one embodiment, the length of the safetytab 648 is selected to correspond to the desired depth of penetrationinto the vertebral body 900, such that the needle cannula 628 willautomatically be inserted the desired depth when the end plate 746 abutsthe proximal end 662 of the handle upper portion 660, as shown in FIG.14B.

With the needle cannula 628 and the pusher member 634 fully advanceddistally relative to the handle 616 and the outer tubular member 620,the tab 748 is positioned in the forward segment 678 of the lower slot674 in the upper handle portion 660. As explained above, the width Wf ofthe forward segment 678 is greater than the width Wr of the rear segment676. As shown in FIG. 14C, the tab 748 (and consequently, the pushermember 634) is then rotated to align the tab 748 and the projection 754with the slots 722, 726 in the proximal portion 696 of the needlecannula 628. Rotation of the tab 748 also aligns the tab 748 with therecess 688 in the forward segment 678 of the lower slot 674 (see FIG.10C). When so aligned, slight proximal movement of the pusher member 634causes the tab 748 to be received in the recess 688, so that subsequentrotation of the tab 748 and the pusher member 634 are prevented by theprojection 686. Additionally, the shoulder 682 formed in the lower slotprevents the pusher member 634 from being displaced proximally when inthis configuration.

With the tab 748 and the projection 754 now aligned with the slots 722,726 in the proximal portion 696 of the needle cannula 628, as shown inFIG. 14D, the lower portion 820 of the lever 646 is then urged into thehandle lower portion 664, thereby pivoting the lever 646 and causing theupper portion 816 of the lever 646 to engage the proximal portion 696 ofthe needle cannula 628 and urge the needle cannula 628 proximallyrelative to the handle 616. As such, the needle cannula 628 is retractedrelative to the pusher member 634, which remains stationary and preventsthe anchor member 650 from being retracted with the needle cannula 628.Accordingly, as shown, the anchor member 650 is ejected from the needlecannula 628 and into the vertebral body 900.

As further shown, retraction of the needle cannula 628 applies a tensileforce to the toggle line 766 attached to the flange 718 of the needlecannula proximal portion 696. This in turn tends to cause the anchormember 650 to rotate as it is ejected from the needle cannula 628, whichencourages positive engagement of the anchor member 650 with thevertebral body 900. In one embodiment, the toggle line 766 is configuredto break at a selected location as the needle cannula 628 is retractedand the tension in the toggle line 766 exceeds a predetermined value,thereby allowing the toggle line 766 to be removed without requiring aseparate cutting step. As shown in FIG. 14E, the delivery tool 600 canthen be removed, leaving the implant 610 in place with the adjustablesuture assembly 654 exposed for use in completing the annular repairprocedure.

FIG. 15A-15C are schematic illustrations showing the implant 610deployed in conjunction with a second implant 1000 to re-approximate anaperture or defect 1018 in a patient's intervertebral disc 1020 adjacenta vertebral body 1022 according to one embodiment of the presentinvention. In the illustrated embodiment, the implant 1000 includes apair of tissue anchors 1025, 1030 connected by an adjustable connectingelement 1034. The implant 1000 can, in various embodiments, besubstantially similar or identical to the implants 25, 400 describedabove, as well as any of the dual anchor fixation devices disclosed, forexample, in co-pending and commonly assigned U.S. patent applicationSer. Nos. 12/251,295 and 12/553,583, and commonly assigned U.S.Provisional Application 61/293,939 the entire disclosures of which areincorporated herein by reference in their entireties. Accordingly, theimplant 1000 is, in various embodiments, deployed using a delivery toolhaving a tubular member with a sharp tissue penetrating tip forpenetrating the disc annulus, wherein the implant 1000 is receivedwithin the tubular member of the aforementioned delivery tool and isdeployed in the annulus fibrosus as disclosed in any of the foregoingU.S. patent applications.

As shown in FIG. 15A, in one embodiment, the implant 610 is implantedwith the anchor member 650 deployed in the patient's vertebral body 1022such that the suture assembly 654 lays across the annular aperture 1018.The implant 1000 is implanted at a location such that the aperture 1018is located between the implant 1000 and the vertebral body 1022. Asshown, the tissue anchor 1025 is implanted in the patient'sintervertebral disc 1020 in such a way that the connecting element 1034extends out of the disc 1020 and through the loop 762 in the implant610. As further shown, the tissue anchor 1030 is implanted at a secondlocation in the disc 1020 using a delivery tool such as the deliverytools 20, 482 described above or any of the fixation deliveryapparatuses disclosed in one of the above-mentioned U.S. patentapplications, and is thereafter tightened using a tension guide or othertechnique. As further shown in FIG. 15A, a tension guide 1050 is usedwhile tension is applied to the tension line 760 of the implant 610(e.g., by pulling on the tab 748 attached to the free end 784 of thetension line 760) to cinch up the tension line 760 and reduce thedimensions of the loop 762. Accordingly, both the suture assembly 654 ofthe implant 610 and the connecting element 1034 of the implant 1000 areplaced in tension and, by virtue of their implantation locations, urgethe edges of the aperture 1018 together and toward the vertebral body1022 to re-approximate the aperture 1018. FIG. 15B illustrates theimplants 610, 1000 in their final implanted configurations, with theaperture 518 at least partially, if not wholly, closed. The implants610, 1000 and the associated delivery tools, e.g., the delivery tool 600and the delivery tool used to deploy the implant 1000 such as disclosedin any of the above-mentioned U.S. patent applications, as well as thetension guide 1050, thus form an annular repair system.

FIG. 15C illustrates an alternative use of the system including theimplants 610, 1000 in their deployed states to repair a defect 1018 inthe annulus fibrosus of the patient's intervertebral disc 1020. In theillustrated embodiment of FIG. 15C, the defect 1018 is a rim lesion,i.e., a tear/delamination of the annulus fibrosus from the vertebralbody 1022 at the insertion point of the annulus into the vertebral body1022. As such, the defect 1018 is located directly adjacent to thevertebral body 1022, such that there is there is little or no annulusfibrosus tissue between the defect 1018 and the vertebral body 1022. Asshown, the implants 610 and 1000 are used to force the edge of theannulus fibrosus of the intervertebral disc 1020 back into contact withthe adjacent surface of the vertebral body 1022 so as to at leastpartially, if not wholly, close the defect 1018.

FIGS. 15D-15F illustrate alternative configurations utilizing one ormore implants 610 and implants 1000 to repair the defect 1018 in theannulus fibrosus. As can be seen in FIGS. 15D-15F, any number ofconfigurations of these implants can be employed to accomplish annulusrepair, depending on the particular therapeutic needs of the patient.

Although in the figures above the anchor member 650 is illustrated andprimarily described as being configured for deployment in the patient'svertebral body for repair of a defect in the adjacent annulus fibrosus,the implant 610, and the delivery tool 600, can also advantageously beused for other orthopedic applications. For example, the anchor member650 can be readily deployed in soft tissue such as the annulus fibrosusitself using the delivery tool 600. In various embodiments, the anchormember 650 can advantageously be deployed in other soft tissues, and thedelivery tool 600 can be used for deploying the anchor member 650 intosuch tissues. Additionally, the use of the implant 610 and the deliverytool 600 is not limited to use in intervertebral disc repair, but mayalso be utilized to repair defects in, for example, the joints in thehand or foot, knee, or shoulder.

FIGS. 16A and 16B are plan views of an alternative embodiment of animplant delivery tool 1070 with an implant 1072 coupled theretoaccording to another embodiment of the present invention. The implantdelivery tool 1070 and the implant 1072 are, except as noted below,substantially the same or identical in structure and function to theimplant delivery tool 600 and the implant 610, respectively, describedabove, and thus need not be described in detail again here. The implant1072 differs from the implant 600 in that the implant 1072 includes atoggle loop 1074 in lieu of the toggle line 766 of the implant 600. Inthe illustrated embodiment, the toggle loop 1074 is releasably retainedagainst the implant delivery tool 1070 by a clip 1076 or other retainingelement prior to deployment. In use, after deploying the anchor member(not shown) of the implant 1072 into bone or other tissue, the toggleloop 1074 is freed from the implant delivery tool 1070 and pulledmanually by the physician to toggle the anchor member and confirm thatthe anchor member is positively engaged with the bone or other tissue.Any remaining length of the toggle line can then be cut away using asuture cutter or other cutting device.

FIGS. 17A-17D are elevation, detail perspective and partialcross-sectional views of the tension guide 1050 shown in FIG. 15A. Asshown in FIGS. 17A-17D, the tension guide 1050 has a body 1090 havingopposite first and second ends 1100, 1110 and a length therebetween. Asfurther shown, the first end 1100 has a canted tip 1115 with a slot 1120sized to slidingly receive a suture. The first end 1100 is thus in manyrespects similar or identical to the corresponding ends of conventionaltension guides and/or knot pushers, and thus need not be described ingreater detail here. In short, in use, a suture tightened is insertedinto the slot 1120 with the canted tip 1115 bearing against theadjustable element (e.g., the locking element 788 of the tension line760 described above, or alternatively, a knot such as a Roeder or Westonknot) to be tightened. Tension is applied to the suture while thetension guide resists movement of the locking element 788 or similarstructure in the direction of the tensile force, so as to cinch up thesuture. The foregoing is illustrated, for example, in FIG. 15A above inconnection with tightening the suture assembly 654 of the implant 610.

As shown in FIG. 17B, the second end 1110 includes a tip 1130 having aslot 1134 extending axially inward thereof. As further shown, within theslot 1134 is a blade 1140 having a cutting edge 1145 oriented toward thetip 1130. As shown, the blade 1140 is recessed inward from the peripheryof the tip 1130, and the cutting edge 1145 is further axially recessedfrom the tip 1130. Thus, no portion of the blade 1140 extends outward ofthe body 1090 of the tension guide 1050. The slot 1134 is dimensioned,e.g., has a width and depth sufficient to freely receive any suture onwhich the tension guide 1050 is used. The blade 1140 is operable to cutaway any excess suture length.

FIG. 17C is a partial cross-sectional elevation view of the second end1110. As shown in FIG. 17C, in one embodiment, the blade 1140 includes aproximal segment 1180 and a distal segment 1184 terminating in the tip1130. As further shown, the distal segment 1184 is angled relative tothe proximal segment 1180 and the longitudinal axis LA of the tensionguide 1050 in general. As further shown, the body 1090 includes aninternal post 1190 to which the blade 1140 is secured. In variousembodiments, the body 1090 further includes a slotted cap 1194 that isplaced over the blade 1140 and the post 1190 and ultrasonically weldedor otherwise secured in place to form the second end 1110 of the tensionguide 1050. The cap 1194 operates to both shield the cutting edge 1145of the blade 1140 as well as secure the blade 1140 to the body 1090.

FIG. 17D is a partial cross-sectional elevation view of the second end1110 of an alternative embodiment of the tension guide 1050 utilizing adifferent blade configuration than that shown in FIG. 17C. In theembodiment of FIG. 17D, the blade 1140 does not include a proximalsegment. Rather, as shown in FIG. 17D, the blade 1140 extends only alongan angled surface of the post 1190 and is mounted and secured to thepost 1190. Additionally, in the embodiment of FIG. 17D, the blade 1140includes a cutout 1205 sized to receive a tab 1210 on the post 1190 tofacilitate mounting the blade 1140 to the post 1190.

In both FIGS. 17C and 17D, the portion of the blade 1140 terminating inthe cutting edge 1145 is angled relative to the longitudinal axis of thetension guide 1050. In various embodiments, the angle α between theactive portion of the blade 1140 and the longitudinal axis can be up to90 degrees. In one embodiment, the angle α is about 45 degrees. Theangle α is selected to allow the user to use a straight approach whencutting the suture (e.g., the body 1090 and the tension guide 1050 ingeneral are generally aligned with the suture being cut). This straightapproach is advantageously employed in procedures in which access islimited. Using the straight approach allows the user to position thesuture in the slot 1134, and once positioned the user can gently pullthe suture straight up and contact the cutting edge 1145 of the blade1140, which severs the suture. The tension guide 1050 can also be usedat any angle that allows the blade 1140 and the cutting edge 1145 tocontact the suture. In various embodiments, the blade 1140 is not angledrelative to the longitudinal axis of the tension guide 1050.

The cutting edge 1145 of the blade 1140 is not limited to any particularconfiguration or profile. In various embodiments, the cutting edge 1145can have a single or double bevel, or a triple angled bevel. In variousembodiments, the cutting edge 1145 can be either single sided or doublesided. In various embodiments, the cutting edge 1145 can have astraight, concave or convex profile.

Thus, the tension guide 1050 advantageously provides a single tool thatcan be used by the clinician to both tighten a suture assembly (e.g.,the suture assembly 654 of the implant 610) and cut away any excesssuture material. Thus in use, the clinician uses the first end 1100 totighten the suture assembly, and then inverts the tension guide 1050 anduses the second end 1110 and the blade 1140 to cut away any excesssuture length. Because the cutting edge 1145 is recessed axially fromthe tip 1130, it is shielded to avoid unintentionally contacting tissueor portions of the suture assembly to be cut. The small diameter and lowprofile shape of the tension guide 1050 provide excellent functionalityand is well adapted for use within the relatively small diameter accesscannulae typically used for annular repair procedures, and eliminatesthe need to use conventional cutting devices, e.g., surgical scissorsand the like, which can be difficult to manipulate within such cannulae.

Although primarily described above in connection with an annulusfibrosus repair procedure, it is emphasized that the tension guide 1050can advantageously be employed in any procedure, including bothorthopedic and non-orthopedic procedures, to provide a safe, quick andefficient means to cut and remove excess suture material and, ifapplicable, tension the suture itself. For example, the tension guide1050 is readily usable in orthopedic procedures such as meniscal repairprocedures as well as shoulder and hip repair procedures. In oneembodiment, the tension guide 1050 may be used to both tighten theconnecting element 300 and remove excess suture material in the implant25 when used to repair a tear or other defect in a meniscus of apatient's knee. Still other applications of the tension guide 1050, bothin sports medicine or other orthopedic repair procedures, will bereadily apparent to the skilled artisan based on the foregoing.

The tension guide 1050 can be made from a number of suitablebiocompatible materials. In various embodiments, the body 1090 can bemade from any of a variety of relatively rigid, biocompatible metal orpolymeric materials. In various embodiments, the body 1090 is made froma polymer such as, without limitation, polypropylene, polyetheretherketone (PEEK™), polyethylene, polyethylene teraphthalate (PET) andpolyurethane, acrylic, polycarbonate, engineering plastics; and/orcomposites. In one embodiment, the body 1090 is made from PEEK™. Theblade 1140 can be made from any of a variety of suitable metals orpolymers. Suitable metals for use in the blade 1140 include, withoutlimitation, stainless steel, nickel, titanium, and titanium and nickelalloys. In one embodiment, the blade 1140 is formed from stainlesssteel. In various embodiments, the blade 1140 includes a coating orother treatment to increase the hardness and wear resistance of theblade material. Suitable materials for the aforementioned coatingsinclude, without limitation, titanium nitride, titanium carbide,titanium carbonitride, chromium nitride, diamond-like coatings,zirconium nitride, titanium aluminum nitride, and various non-stickmaterials such as polytetraflouroethylene (PTFE) and expanded PTFE. Inother embodiments, the blade 1140 is not coated.

FIGS. 18A-18B are schematic illustrations of the implant 25 in use torepair a tear or other defect 1300 in a meniscus 1310 of a patient'sknee according to yet another embodiment of the present invention. Asshown in FIGS. 18A and 18B, in one embodiment, the tissue anchors 125 aand 125 b can be deployed on the outer surface of the meniscus 1310 withthe connecting element 300 extending through the meniscus 1310 andbearing against the inner surface of the meniscus 1310 proximate thetear 1300. Thus, as shown in FIG. 18B, the connecting element 300 isirreversibly shortened using the tension guide 1050, and the meniscaltissue adjacent to the tear 1300 is urged together to effectuate therepair. Any excess suture material of the connecting element 300 isthereafter cut away using the tension guide 1050 as described above.Although FIGS. 18A and 18B illustrate the use of only a single implant25, in various embodiments, additional implants 25 and/or implants 400can be used to accomplish the meniscal repair. In still otherembodiments, the implants 25, 400 can be used for other orthopedicrepair procedures in the knee, shoulders, hips, and the like.

The materials used in the implants 610, 1000, 1072, and the deliverytools 600, 1010, 1070 can include any number of biocompatible materialshaving suitable mechanical properties. For example, materials from whichto make the anchor member 650 and the tissue anchors 1025, 1030 caninclude, but are not limited to: metals, such as stainless steel,nickel, titanium alloy, and titanium; plastics, such aspolytetrafluoroethylene (PTFE), polypropylene, polyether etherketone(PEEK™), polyethylene, polyethylene teraphthalate (PET) andpolyurethane, acrylic, polycarbonate, engineering plastics; and/orcomposites. The adjustable suture assembly 654 and the connectingelement 1034 can likewise be made of any suitable suture material. Invarious embodiments, the anchor member 650, the tissue anchors 1025,1030 and/or the adjustable suture assembly 654 and the connectingelement 1034 can be made of bio-resorbable materials. In variousembodiments, the tension line 760, the toggle line 766 and theconnecting segment 770 of the implant 610 are made wholly or partiallyof size 2-0 or 3-0 ultra high molecular weight polyethylene (UHMWPE)suture material, otherwise known as force fiber suture material. In oneembodiment, the anchor member 650 is made from PEEK, the tension line760 and the connecting segment 770 are made from size 2-0 UHMWPE suturematerial, and the toggle line 766 is made from size 3-0 UHMWPE suturematerial. In short, any suitable materials, whether now known or laterdeveloped, can be utilized to construct the implant 610 within the scopeof the present invention.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. For example, while the embodiments described above refer toparticular features, the scope of this invention also includesembodiments having different combinations of features and embodimentsthat do not include all of the described features. Accordingly, thescope of the present invention is intended to embrace all suchalternatives, modifications, and variations as fall within the scope ofthe claims, together with all equivalents thereof.

The following is claimed:
 1. A tissue repair or fixation devicecomprising: first and second tissue anchors sized and shaped to bedisposed in a tubular member of a delivery tool; and a flexibleconnecting element coupling the first and second tissue anchors, theconnecting element at least partially formed from a tubular braidedsuture material and including: a distal segment of the braided suturematerial attached to the first tissue anchor; an intermediate segment ofthe braided suture material extending proximally from the distal segmentand including a locking element and an adjustable loop, wherein aportion of the intermediate segment extends internally within thebraided suture material of the locking element, and wherein the secondtissue anchor is slidably coupled to the braided suture material of theadjustable loop; and a proximal segment of the braided materialextending proximally from the intermediate segment and operable by auser to be placed in tension to reduce the length of the adjustableloop.
 2. The tissue repair or fixation device of claim 1, wherein thebraided suture material is tubular and includes an outer wall, andwherein the locking element has a proximal end and a distal end, andwherein the portion of the intermediate segment extending internallywithin the braided suture material of the locking element enters thebraided suture material at the proximal end of the locking element andexits the braided suture material at the distal end of the lockingelement.
 3. The tissue repair or fixation device of claim 1, wherein thebraided suture material is tubular and includes an outer wall, andwherein the locking element has a proximal end and a distal end, andwherein the portion of the intermediate segment extending internallywithin the braided suture material of the locking element enters thebraided suture material at the distal end of the locking element andexits the braided suture material at the proximal end of the lockingelement.
 4. The tissue repair or fixation device of claim 1, furthercomprising a retention line coupled to the second tissue anchor andextending proximally within the pusher tube, the retention line operableto inhibit ejection of the second tissue anchor from the delivery toolduring deployment of the first tissue anchor.
 5. The tissue repair orfixation device of claim 4, wherein the second tissue anchor is slidablycoupled to the braided suture material of the adjustable loop by asuture loop disposed around the braided suture material and attached tothe second tissue anchor.
 6. The tissue repair or fixation device ofclaim 5, wherein the retention line is coupled to the suture loop. 7.The tissue repair or fixation device of claim 6, wherein the firsttissue anchor is fixedly attached to the distal segment of the braidedsuture material by a knot, and wherein the distal segment extendsproximally from the first tissue anchor to the intermediate segment ofthe braided suture material.
 8. The tissue repair or fixation device ofclaim 1, wherein the flexible connecting element further comprises aresistance feature located proximal to the locking element, theresistance feature dimensioned to contact an inner surface of thetubular member of the delivery tool prior to deployment of the tissuerepair or fixation device therefrom.
 9. The tissue repair or fixationdevice of claim 8, wherein the resistance feature is a knot or aresilient sphere or cylinder disposed over the suture material of theconnecting element.
 10. The tissue repair or fixation device of claim 1,wherein the flexible connecting element is made from a single length ofsuture material.
 11. The tissue repair or fixation device of claim 1,wherein the first and second tissue anchors are made from stainlesssteel, nickel, titanium alloy, or titanium.
 12. The tissue repair orfixation device of claim 1, wherein the first and second tissue anchorsare made from polytetrafluoroethylene, polypropylene, polyetheretherketone, polyethylene, polyethylene terephthalate, polyurethane,acrylic or polycarbonate.
 13. The tissue repair or fixation device ofclaim 1, wherein the suture material of the connecting element is a size2-0 or size 3-0 force fiber suture material.
 14. A tissue repair orfixation system comprising: a delivery tool having a substantially rigidouter tube with a pusher tube slidably disposed within the outer tube;and a tissue repair or fixation device releasably coupled to thedelivery tool including: a pair of tissue anchors serially disposedwithin a distal section of the outer tube; and a flexible connectingelement coupling the tissue anchors, the connecting element at leastpartially formed from a braided tubular suture material and including: adistal segment of the braided suture material attached to the firsttissue anchors an intermediate segment of the braided suture materialextending proximally from the distal segment and including a knotlesslocking element and an adjustable loop, wherein the second tissue anchoris slidably coupled to the braided suture material of the adjustableloop; a proximal segment of the braided suture material extendingproximally from the intermediate segment and releasably coupled to thedelivery tool; and a retention line coupled to the second tissue anchorand extending proximally within the pusher tube, the retention lineoperable to inhibit ejection of the second tissue anchor from thedelivery tool during deployment of the first tissue anchor.
 15. Thetissue repair or fixation system of claim 14, wherein the second tissueanchor is slidably coupled to the braided suture material of theadjustable loop by a suture loop disposed around the braided suturematerial and attached to the second tissue anchor.
 16. The tissue repairor fixation system of claim 15, wherein the retention line is coupled tothe suture loop.
 17. The tissue repair or fixation device of claim 14,wherein the flexible connecting element further comprises a resistancefeature located proximal to the locking element, the resistance featuredimensioned to contact an inner surface of the outer tube of thedelivery tool prior to deployment of the tissue repair or fixationdevice therefrom.
 18. The tissue repair or fixation system of claim 17,wherein the resistance feature is a knot or a resilient sphere orcylinder disposed over the suture material of the connecting element.19. The tissue repair or fixation system of claim 14, wherein theflexible connecting element is made from a single length of suturematerial.
 20. The tissue repair or fixation system of claim 14, whereinthe suture material of the connecting element is a size 2-0 or size 3-0force fiber suture material.